The subject of this patent application relates generally to medical immobilization or orthotic devices, and more particularly to multifunctional orthosis devices and their use.
Applicant(s) hereby incorporate herein by reference any and all patents and published patent applications cited or referred to in this application.
By way of background, immobilization of fractured or injured joints or limbs typically involves the process of restraining the joint or limb in place with a splint, cast, or brace. This is done to prevent the fractured/injured area from moving or being disturbed during the healing process.
Traditionally Plaster of Paris on fabric or gauze bandage has been used to form casts for the immobilization of limbs. However, Plaster of Paris has a number of disadvantages associated with it. For example, Plaster of Paris is relatively heavy and bulky, has a slow setting time, cannot be reformed once set, possesses low impact resistance, and is susceptible to deterioration or damage once exposed to moisture thus making bathing and showering difficult. Additional concerns associated with the use of Plaster of Paris casting bandages are that they require a significant amount of time, usually 24 to 72 hours, to achieve their maximum strength, and that heat is generated from the exothermic setting reaction. Plaster of Paris also has poor radiopacity, which often prevents the continued monitoring of the limb during the healing process. In addition, Plaster of Paris is substantially impervious to transmission of water vapor, such as perspiration. Thus, Plaster of Paris traps moisture, which can result in significant skin maceration.
One partial solution to improve breathability is the use of a thermoplastic mesh as disclosed in U.S. Pat. No. 4,143,655 to Custer et al. A drawback with this method, however, is the necessity to apply multiple layers of mesh to achieve adequate strength to support and protect body areas. Another drawback of this method is that the mesh needs to be trimmed in order to fit different body areas and this results in sharp edges that are formed due to trimming. Another disadvantage of this method is that underlying bandages, padding, dressings, and gauzes can become wet because the material is usually heated using a hot water bath to soften the material to facilitate molding. Moist dressings promote bacteria growth and can lead to discomfort and further complications.
Other proposed solutions involve the use of thermoplastic materials. It is usually prescribed that thermoplastic mesh and thermoplastic sheets with perforations are heated using a water bath. This will help to reduce the (unwanted) high tack characteristic associated with these materials, which makes it otherwise difficult for the user to handle. However, this means that these devices and materials are often wet when applied which can in some instances sustain bacteria growth and MRSA or more generally just be unpleasant for the patient.
In the case of splints and casts it is important that such devices and materials also have sufficient strength to maintain correct alignment of fractured bones, or to restrict movement of a limb in order to promote healing, or to stabilize and help reduce swelling of injured limbs, or to protect a body area from impact and injury. Specifically, in cases where devices or materials are used to protect body parts from impact and injury it is important that the devices or materials have sufficient strength to withstand an impact and also be capable of transmitting/dissipating the force of the impact onto and across underlying padding or shock absorbing materials to reduce or prevent injury to the underlying body part on humans and animals.
Those skilled in the art will recognize the importance of having breathable and open surfaces in devices and materials used for immobilization, bracing, casting, protection, or support of limbs and body parts on humans and animals in order to reduce skin maceration problems and clinical complications and to promote a reduction of healing times while still providing the aforementioned strength and workability and convenience in use.
In the context of hand orthotic devices, so-called “gutter splints” are used to protect, immobilize, and/or cast metacarpal bones and phalanges. Typical metacarpal fractures of the hand on the ulnar side are the 4th and 5th metacarpals, with the 5th metacarpal (little finger) being the most common. As such, the most common gutter splint is nicknamed a “boxer splint” because people often break the 5th metacarpal bone (little finger knuckle) after throwing a punch, or more generally as a result of striking hard object with a fist. The conventional name for a product used to treat this injury to the 5th metacarpal and also the 4th metacarpal bone beside it is an “ulnar gutter.” Fractures of the 2nd and 3rd metacarpals on the radial side are less common, hence treatment of the radial side is less common. Radial configuration requires an opening in the gutter splint for the thumb which allows free movement of the thumb while immobilizing the 2nd and 3rd finger. The common name for a product used to treat fractures of the 2nd and 3rd metacarpal bones (fingers next to the thumb) is typically called a “radial gutter.”
Traditionally Plaster of Paris or synthetic resin fiberglass have been used to fabricate ulnar gutter splints and radial gutter splints, which materials have the shortcoming noted above. Moreover, the procedure is difficult and requires skill on the part of the plaster technician to make an effective gutter. Furthermore, plaster gutters are generally uncomfortable, heavy and cumbersome, and as indicated above are not breathable or wettable, which may result in itch, odor, and/or discomfort for the patient. In some cases occupational therapists fabricate gutter splints from thermoplastic sheets. This also requires great skill, and both procedures are time consuming. Finally, custom orthotics, which might adequately address some of the concerns regarding functionality or effectiveness, are yet expensive and require additional padding and liner elements which are not usually suitable for exposure to water. Further, conventional custom or pre-formed orthotics and their materials of construction are restrictive for metacarpal fractures and other injuries requiring isolation or need to constrain movement of the fingers, resulting in therapeutic limitations in cases where injuries and rehabilitation regimes require that the fingers are allowed to flex or extend only over a limited range.
More recently, prefabricated thermoplastic devices have been deployed with limited success due to the material configurations chosen and design employed in those devices. These devices can be difficult to mold particularly for position of function and support of the metacarpal heads and have limited breathability due to low surface openness of those devices. That is, fingers are typically molded into a bent position to allow full recovery of flexion/extension post-treatment and such that the knuckles or metacarpal heads are well supported, but the degree of molding that is possible is challenging with the current state of the art materials, particularly with both resin/fiber and pre-cut or prefabricated thermoplastic splints. Furthermore, such prefabricated thermoplastic devices can essentially only be used for a single indication and are not universal (ambidextrous). For example, a discrete prefabricated thermoplastic device product is needed for each of the following:
RH Ulnar Gutter×1
LH Ulnar Gutter×1
RH Radial Gutter×1
LH Radial Gutter×1
Total=4 Discrete devices needed.
Thus, typically with prefabricated thermoplastic devices found in the art, five (5) sizes are needed to cover the population, therefore four product types times five sizes equals twenty (4×5=20) devices needed to cover the general population. This represents added cost and a challenge for inventory management and stocking levels especially for small clinics.
Therefore, currently the market is poorly served with effective product solutions.
The present specification addresses the shortcomings of known orthotic devices particularly in the context of gutter orthotics as might be employed in or as hand gutter splints.
Aspects of the present invention fulfill these needs and provide further related advantages as described in the following summary.